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The purpose of this phase I/II trial is to evaluate safety and tolerability of a single dose of GHB16L2 administered by liquid nasal spray for vaccination against seasonal influenza virus infection. It is also performed to assess immunogenicity and pharmacokinetics (shedding).

Condition or disease

Intervention/treatment

Phase

Influenza, Human

Biological: GHB16L2Biological: Placebo

Phase 1Phase 2

Detailed Description:

GHB16L2 intends to provide a novel vaccination for influenza virus infection. 80 healthy volunteers will be included at a ratio of 1:1 for GHB16L2 or placebo. GHB16L2 will be administered once on day 1. Follow-up visits will be performed on days 2, 8 and 29.

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Ages Eligible for Study:

18 Years to 60 Years (Adult)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Criteria

Inclusion Criteria:

Healthy male and female volunteers, 18-60 years

Seronegative for one or two of the applied vaccine strains

Low antibody titres for H1N1v

Written informed consent to participate in this study

For female volunteers of childbearing potential, provision of a history and current use of reliable contraceptive practices

Exclusion Criteria:

Acute febrile illness (>37.3°C)

Signs of acute or chronic upper or lower tract respiratory illnesses

History of severe atopy

Seasonal influenza vaccination in 2008/2009 and/or later seasons and/or pandemic influenza vaccination at any time

Fever ≥38.0°C in the time period between the pre-screening visit and day 1